FDA grants priority approval to arsenic trioxide (Trisenox) plus tretinoin for leukemia treatment.
Teva Pharmaceuticals recently announced the FDA has approved arsenic trioxide (Trisenox) plus tretinoin as a first-line treatment for patients with low-risk acute promyelocytic leukemia (APL), according to a press release.
The newly-approved combination therapy is indicated for patients with APL that is characterized by t(15;17) translocation or PML/RAR-alpha gene expression, Teva reported.
Approval for arsenic trioxide plus tretinoin was based on priority review by the FDA due to positive results from clinical trials.
“Today’s approval to expand the indication of Trisenox is a testament to Teva’s commitment to providing solutions to advance cancer care,” said Paul Rittman, senior vice president and general manager, Teva Oncology. “This label expansion represents an important benefit as Trisenox is now an FDA-approved first line treatment option for patients with acute promyelocytic leukemia.”
The new indication for APL is in line with the current guidelines set by the National Comprehensive Cancer Network, according to the release.
Common adverse reactions include leukocytosis, neutropenia, thrombocytopenia, nausea, vomiting, diarrhea, abdominal pain, hepatic toxicity, fever, rigors, fatigue, insomnia, tachycardia, QTc prolongation, edema, hyperglycemia, hypokalemia, hypomagnesemia, dyspnea, cough, rash or itching, sore throat, arthralgia, headaches, paresthesia, and dizziness.
Previously, the FDA approved arsenic trioxide for induction of remission and consolidation in patients with APL who were previously treated with retinoid and anthracycline chemotherapy, and whose disease expresses the t(15;17) translocation or PML/RAR-alpha, according to the release.